Modular transdermal delivery system and associated methods of manufacture and use

Abstract

A modular transdermal drug delivery system is provided, the system including: an upper module in which an outer backing layer is laminated to a pressure-sensitive adhesive layer that is covered by a removable release liner prior to assembly; and a lower module with a porous drug reservoir layer laminated to a skin-contact adhesive that affixes the system to the skin during drug delivery, where the skin-contact adhesive is, in one embodiment, an adhesive layer that is substantially co-extensive with the porous drug reservoir layer and, prior to use, protected with a second removable release liner. Methods of manufacture and use are also provided, as is an assembled transdermal drug delivery system fabricated by affixing the pressure-sensitive adhesive layer of the upper module to the porous drug reservoir layer of the lower module.

1 . A modular transdermal delivery system for pre-use assembly and drug loading, wherein the system comprises:
 an upper module comprising an outer backing layer, a pressure-sensitive adhesive layer laminated thereto, and a first removable release liner covering the pressure-sensitive adhesive layer; and   a lower module comprising a porous drug reservoir layer for adhering to the pressure-sensitive adhesive layer of the upper module upon assembly and into which the drug to be delivered will be loaded, and a skin-contact adhesive affixed to the drug reservoir layer,   wherein the system is free of a pharmacologically active agent.   
     
     
         2 . (canceled) 
     
     
         3 . The system of  claim 1 , wherein the porous drug reservoir layer comprises a microporous polymeric matrix. 
     
     
         4 - 5 . (canceled) 
     
     
         6 . The system of  claim 1 , wherein the skin-contact adhesive comprises a skin-contact adhesive layer that is laminated to the drug reservoir layer and serves as the basal surface of the system which adheres to a body surface during use. 
     
     
         7 . The system of  claim 6 , further including a second removable release liner adhered to the skin-contact adhesive layer and thereby covering the basal surface of the system prior to use. 
     
     
         8 . (canceled) 
     
     
         9 . The system of  claim 1 , wherein the pressure-sensitive adhesive layer contains a permeation enhancer. 
     
     
         10 - 11 . (canceled) 
     
     
         12 . The system of  claim 1 , wherein the basal surface of the system has an area in the range of about 5 cm 2  to about 100 cm 2 . 
     
     
         13 . (canceled) 
     
     
         14 . The system of  claim 1 , wherein the first removal release liner is scored or perforated to facilitate removal of the liner in at least two segments, sequentially. 
     
     
         15 . The system of  claim 1 , wherein the skin-contact adhesive comprises a peripheral ring underlying the drug reservoir layer. 
     
     
         16 . The system of  claim 6 , wherein the lower module further includes a release rate-controlling membrane between the porous drug reservoir layer and the skin contact adhesive layer. 
     
     
         17 . A modular transdermal delivery system for pre-use assembly, wherein the system comprises:
 an upper module comprising an outer backing layer, a pressure-sensitive adhesive layer laminated thereto, and a first removable release liner covering the pressure-sensitive adhesive layer; and   a lower module comprising a porous drug reservoir layer for adhering to the pressure-sensitive adhesive layer of the upper module upon assembly, a skin-contact adhesive affixed to the drug reservoir layer, and, contained within the porous drug reservoir layer, a pharmaceutical formulation containing a pharmacologically active agent or a precursor thereto.   
     
     
         18 . (canceled) 
     
     
         19 . The system of  claim 17 , wherein the porous drug reservoir layer comprises a microporous polymeric matrix. 
     
     
         20 - 21 . (canceled) 
     
     
         22 . The system of  claim 17 , wherein the skin-contact adhesive comprises a skin-contact adhesive layer that is laminated to the drug reservoir layer and serves as the basal surface of the system which adheres to a body surface during use. 
     
     
         23 . The system of  claim 22 , further including a second removable release liner adhered to the skin-contact adhesive layer and thereby covering the basal surface of the system prior to use, wherein the second removable release liner is optionally scored or perforated. 
     
     
         24 . The system of  claim 22 , wherein the skin contact adhesive layer is comprised of a material selected to be permeable to the pharmaceutical formulation. 
     
     
         25 . The system of  claim 17 , wherein the pressure-sensitive adhesive layer contains a permeation enhancer. 
     
     
         26 . The system of  claim 17 , wherein the pharmaceutical formulation comprises a pharmacologically active agent. 
     
     
         27 . The system of  claim 17 , wherein the pharmaceutical formulation comprises a precursor to a pharmacologically active agent. 
     
     
         28 . The system of  claim 27 , wherein the pressure-sensitive adhesive layer contains an activator compound for converting the precursor to the pharmacologically active agent. 
     
     
         29 . The system of  claim 26 , wherein the pressure-sensitive adhesive layer comprises a composition that exhibits low partitioning for the pharmacologically active agent. 
     
     
         30 . The system of  claim 17 , wherein the basal surface of the system has an area in the range of about 5 cm 2  to about 100 cm 2 . 
     
     
         31 . (canceled) 
     
     
         32 . The system of  claim 17 , wherein the first removal release liner is scored or perforated to facilitate removal of the liner in at least two segments, sequentially. 
     
     
         33 . The system of  claim 17 , wherein the skin-contact adhesive comprises a peripheral ring underlying the drug reservoir layer. 
     
     
         34 . The system of  claim 17 , wherein the lower module further includes a release rate-controlling membrane between the porous drug reservoir layer and the skin contact adhesive layer. 
     
     
         35 - 71 . (canceled) 
     
     
         72 . The system of  claim 1 , wherein the porous drug reservoir layer has a porosity gradient such that porosity gradually decreases from an uppermost region of the reservoir layer to a lowermost region of the reservoir layer. 
     
     
         73 . The system of  claim 17 , wherein the porous drug reservoir layer has a porosity gradient such that porosity gradually decreases from an uppermost region of the reservoir layer to a lowermost region of the reservoir layer.